Treatment with the inhaled levodopa formulation CVT-301 provides rapid motor symptom relief during off periods, with consistent efficacy seen across Parkinson’s disease (PD) patients of all ages, according to a post hoc analysis of three phase III trials.
Analysis of data from a total of 437 PD patients ages 37 to 82 years who received 84 mg of CVT-301 showed reductions in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III scores at 30 min post-dose at week 12. [EAN 2026, abstract PO-0659]
The reductions in UPDRS-III scores ranged from –5.7 among those who were ≥75 years of age at the time of diagnosis to –16.4 among those who were <55 years of age at study treatment initiation, the authors reported.
“It is worth noting that the subgroup of patients who were ≥75 years at the time of diagnosis was small (n=3) and, therefore, may not be representative,” they pointed out.
Reductions of at least 30 percent in UPDRS-III scores at 30 min post-dose were seen in at least 64.5 percent of patients across all subgroups of age at study treatment initiation.
The authors noted that the reduction in UPDRS-III scores aligned with improvements on the Patients’ Global Impression of Change (PGIC) scale across all age groups.
In patient subgroups defined by age at treatment initiation, for instance, PGIC improvements were reported by 73 percent of those who were <55 years of age, 84.6 percent of those who were 55–64 years of age, 86.5 percent of those who were 65–74 years of age, and 79.4 percent of those who were ≥75 years of age.
Taken together, the results for UPDRS-III scores and PGIC establish the value of CVT-301 as an on-demand treatment option for the management of off periods, the authors noted. This holds important implications since off periods impose a substantial burden on patients and their caregivers, given the debilitating and unpredictable nature of the episodes, they added.
For the post hoc analysis, the authors pooled data from the phase III CVT-301-004, CVT-301-004e, and CVT-301-005 trials. These trials involved patients ages 30–85 years with idiopathic stage 1–3 PD who experienced off episodes for ≥2 h per day and received 84 mg of CVT-301.
Analyses were conducted across subgroups based on age at diagnosis, age at start of first off episode, and age at initiation of study treatment, as follows: <55, 55–64, 65–74, and ≥75 years.
The mean age of the 437 patients was 63.5 years, 64.3 percent were male, and 96.3 percent were White. The mean time since diagnosis was 8.7 years, the mean time since the first off episode was 3.8 years, and the mean age at study initiation was 63.5 years.
“Orally administered levodopa is the first-line treatment of motor symptoms in patients with PD. However, many of them develop motor response fluctuations, known as off episodes, within a few years of initiating treatment,” the authors said.
“CVT-301 is an inhaled formulation of levodopa developed for the treatment of episodic off periods,” they added.